Blinatumomab

(Blincyto®)

Blincyto®

Drug updated on 9/4/2024

Dosage FormInjection (intravenous: 35 mcg)
Drug ClassCD19-directed CD3 T-cell engagers
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
  • Indicated for the treatment of adults and pediatric patients with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL).

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Summary
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  • Blincyto (blinatumomab) is indicated for the treatment of adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%, and for the treatment of adults and pediatric patients with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL).
  • This summary is based on the review of 15 systematic review(s)/meta-analysis(es). [1-15]
  • Blinatumomab exhibited a complete remission (CR) rate of 31% to 56% across different studies, with higher rates in patients with bone marrow (BM) blasts <50%. Specifically, CR rates were 56% in pediatric patients with relapsed/refractory B-ALL, 54% in adult and pediatric patients with B-ALL, 45% in relapsed/refractory ALL, and 20% in NHL patients.
  • Median overall survival with blinatumomab was 7.7 months versus 4.0 months with standard chemotherapy. Pediatric patients with relapsed/refractory B-ALL had an overall survival (OS) of 0.43. The 2-year OS was 25% for blinatumomab compared to 55% for CAR T-cell therapy.
  • Minimal Residual Disease response rates varied between 31% and 51%, with a rate of 51% in pediatric patients with relapsed/refractory B-ALL and a pooled rate of 42% in ALL patients.
  • The event-free survival rate in pediatric patients was 30%, while the median relapse-free survival (RFS) was 6.02 months. The 2-year RFS was 22% with blinatumomab compared to 40% with CAR T-cell therapy.
  • The pooled occurrence rate of grade ≥3 adverse effects (AEs) was 80%, with specific incidences for neurological toxicity at 7% and cytokine release syndrome (CRS) at 3%.
  • The incidence of grade ≥3 neurological toxicity was 7%, and the risk of encephalopathy was significantly higher with blinatumomab compared to chemotherapy (relative risk, 8.90).
  • Blinatumomab was associated with a lower rate of grade ≥3 hematological toxicity, CRS, and neurological events compared to CAR T-cell therapy, and had fewer grade ≥3 AEs compared to chemotherapy, including a lower risk of febrile neutropenia and infections.
  • Specific populations mentioned include pediatric patients with relapsed/refractory B-ALL, adults with relapsed/refractory B-ALL, and children with B-precursor ALL and B-cell lymphoma. Subgroup findings highlighted that CR rates were higher in patients with bone marrow blasts <50%, and prior allogeneic hematopoietic stem cell transplant did not affect CR rates. Blinatumomab may be particularly beneficial as a bridge to hematopoietic stem cell transplantation, with careful monitoring of safety profiles, especially in pediatric populations.

Product Monograph / Prescribing Information

Document TitleYearSource
Blincyto (blinatumomab) Prescribing Information.2024Amgen Inc., Thousand Oaks, California

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparison of blinatumomab and CAR T-cell therapy in relapsed/refractory acute lymphoblastic leukemia: a systematic review and meta-analysis.2024Expert Review of Hematology
Efficacy and safety of blinatumomab in children with relapsed/refractory B cell acute lymphoblastic leukemia: A systematic review and meta-analysis.2023Frontiers in Pharmacology
Efficacy and safety of blinatumomab for the treatment of relapsed/refractory acute lymphoblastic leukemia: A systemic review and meta-analysis.2023Clinical Lymphoma, Myeloma and Leukemia
Comparing the efficacy of salvage regimens for relapsed/refractory B-cell acute lymphoblastic leukaemia: A systematic review and network meta-analysis.2022Annals of Hematology
Systematic review of costs and cost-effectiveness of treatment for relapsed/refractory acute leukemia in children and young adults.2022Expert Review of Hematology
The safety of blinatumomab in pediatric patients with acute lymphoblastic leukemia: A systematic review and meta-analysis.2022Frontiers in Pediatrics
Clinical pharmacology of cytotoxic drugs in neonates and infants: Providing evidence-based dosing guidance. 2022European Journal of Cancer
Blinatumomab in pediatric acute lymphoblastic leukemia-from salvage to first line therapy (A systematic review).2021Journal of Clinical Medicine
Commonly reported adverse events associated with pediatric immunotherapy: A systematic review from the Children’s Oncology Group.2021Journal of Pediatric Oncology Nursing
Evidence-based recommendations for nurse monitoring and management of immunotherapy-induced cytokine release syndrome: A systematic review from the Children’s Oncology Group.2021Journal of Pediatric Oncology Nursing
Efficacy of targeted immunotherapy as induction or salvage therapy in acute lymphoblastic leukemia: A systematic review and meta-analysis.2021Technology in Cancer Research & Treatment
A systematic review of blinatumomab in the treatment of acute lymphoblastic leukemia: Engaging an old problem with new solutions. 2021Annals of Pharmacotherapy
Blinatumomab as first salvage versus second or later salvage in adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia: Results of a pooled analysis.2021Cancer Medicine
Commonly reported adverse events associated with pediatric immunotherapy: a systematic review from the children's oncology group.2020Journal of Pediatric Oncology Nursing
Efficacy and safety of bispecific T-cell engager (BiTE) antibody blinatumomab for the treatment of relapsed/refractory acute lymphoblastic leukemia and non-Hodgkin’s lymphoma: A systemic review and meta-analysis.2019Hematology

Clinical Practice Guidelines